Keppra IV for the Treatment of Motor Fluctuations in Parkinson's Disease

This study has been withdrawn prior to enrollment.
(Study withdrawn due to personnel limitations.)
Sponsor:
Information provided by:
University of South Florida
ClinicalTrials.gov Identifier:
NCT00584025
First received: December 21, 2007
Last updated: June 2, 2008
Last verified: June 2008
  Purpose

The primary purpose of this study is to characterize the acute anti-dyskinetic properties of intravenous levetiracetam in Parkinson's disease patients who have been optimized on antiparkinsonian medication. The secondary objective is to study the effect of intravenous LEV on additional motor and cognitive symptoms of PD.


Condition Intervention Phase
Parkinson's Disease
Drug: levetiracetam
Drug: Placebo
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double Blind (Subject, Investigator, Outcomes Assessor)
Primary Purpose: Treatment

Resource links provided by NLM:


Further study details as provided by University of South Florida:

Primary Outcome Measures:
  • Abnormal Involuntary Movements Scale (AIMS) [ Time Frame: 15 minutes ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Rush Dyskinesia Rating Scale [ Time Frame: 15 minutes ] [ Designated as safety issue: No ]

Estimated Enrollment: 20
Study Start Date: December 2007
Estimated Primary Completion Date: August 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1
Keppra IV
Drug: levetiracetam
100 - 500mg IV q 15 min
Placebo Comparator: 2
Placebo
Drug: Placebo
Placebo equivalent of 100 - 500 mg levetiracetam IV q 15 min

  Eligibility

Ages Eligible for Study:   30 Years to 80 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Outpatients with idiopathic PD according to the UK Parkinson's Disease Society Brain Bank Clinical Diagnosis Criteria.
  2. Age 30 years to 80 years.
  3. Dyskinesias with a minimum severity equal to a rating of 10 or higher on the AIMS rating scale at baseline.
  4. Dyskinesias at least moderately disabling (historical information from item 33 of UPDRS).
  5. Stable dose of antiparkinsonian medication 4 weeks prior to study entry.
  6. Women of child-bearing potential must use a reliable method of contraception and must be willing to perform a pregnancy test paid for and provided by Dr. Zesiewicz and the USF Medical Clinic. There must be a negative result before entry into the study.

Exclusion Criteria:

  1. Any illness that in the investigator's opinion preclude participation in this study. This includes patients with unstable disease and those PD patients who can not tolerate IV infusion.
  2. Pregnant or lactating women. Pregnancy will not be allowed whether as a pre-existing condition or a positive result on the pregnancy test in the screening process. Lactation includes any woman wanting to participate who is currently breast-feeding.
  3. Patients may not be dual enrolled to another research study requiring the patient to sign informed consent.
  4. Dementia or other psychiatric illness that prevents the patient from giving informed consent (Mini Mental Status Exam score of less than 20).
  5. Legal incapacity or limited legal capacity.
  6. Presence of severe renal disease (BUN 50% greater than normal). Patients must have evidence from their PCP or Urologists of normal PSA and urodynamic tests within the last 12 months; patients with BUN 50% greater than normal (5 to 20 mg/ d L) or creatinine 50% greater than normal (0 .7 and 1.4 mg/ d L) will be excluded. Labs will be requested from PCP.
  7. Concomitant or prior therapy with the following treatments: neuroleptics, metoclopramide, domperidone (in doses >60mg/day), azole antifungals (e.g. ketoonazole), etomidate, ciprofloxacin, fluvoxamine, cimetidine, fludrocortizone, encainide, flecainide, mexiletine, propafenone, guanoxane, maprotiline, antidepressants on doses higher than the maximum approved daily dose for outpatients, intermittent therapy with oral corticoids.
  8. Patients who are not fluent in English.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00584025

Locations
United States, Florida
University of South Florida
Tampa, Florida, United States, 33612
Sponsors and Collaborators
University of South Florida
Investigators
Principal Investigator: Theresa A Zesiewicz, MD University of South Florida
  More Information

No publications provided

Responsible Party: Theresa Zesiewicz, MD, University of South Florida
ClinicalTrials.gov Identifier: NCT00584025     History of Changes
Other Study ID Numbers: 5
Study First Received: December 21, 2007
Last Updated: June 2, 2008
Health Authority: United States: Institutional Review Board

Keywords provided by University of South Florida:
Parkinson's disease
dyskinesia
levetiracetam
keppra

Additional relevant MeSH terms:
Parkinson Disease
Basal Ganglia Diseases
Brain Diseases
Central Nervous System Diseases
Movement Disorders
Nervous System Diseases
Neurodegenerative Diseases
Parkinsonian Disorders
Etiracetam
Anticonvulsants
Central Nervous System Agents
Nootropic Agents
Pharmacologic Actions
Therapeutic Uses

ClinicalTrials.gov processed this record on October 21, 2014